Status:
NOT_YET_RECRUITING
Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute of Allergy and Infectious Diseases (NIAID)
Pham Ngoc Thach University of Medicine
Conditions:
Talaromycosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
LAmB-FAST is a factorial randomized controlled trial simultaneously testing two interventions in one trial. LAmB-FAST seeks to inform treatment guidelines on the induction and maintenance therapy of H...
Detailed Description
Talaromycosis (formerly known as penicilliosis) is caused by the dimorphic fungus Talaromyces marneffei (Tm) endemic in Southeast Asia where it is a leading the cause of death among people with advanc...
Eligibility Criteria
Inclusion
- HIV infected adults (age greater or equal to 18), on ART or no ART
- Definitive talaromycosis confirmed by microscopy, histology, or culture
Exclusion
- Known severe allergy to AmB or 5FC
- Absolute neutrophil count \<500 cells
- Concurrent cryptococcal or TB meningitis
- Received \> 2 doses of DAmB
- Pregnancy
Key Trial Info
Start Date :
April 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2031
Estimated Enrollment :
428 Patients enrolled
Trial Details
Trial ID
NCT06525389
Start Date
April 1 2026
End Date
November 1 2031
Last Update
December 17 2025
Active Locations (5)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710
2
Bach Mai Hospital
Hanoi, Vietnam
3
National Hospital for Tropical Diseases
Hanoi, Vietnam
4
Hospital for Tropical Diseases
Ho Chi Minh City, Vietnam, 7000